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Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.

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Title: Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.
Authors: Chen B; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA., Nagai S; Translational Research Center, The University of Tokyo Hospital, Tokyo, Japan., Armitage JO; University of Nebraska School of Medicine, Omaha, Nebraska, USA., Witherspoon B; College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA., Nabhan C; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Godwin AC; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Yang YT; Center for Health Policy and Media Engagement, George Washington University, Washington, D.C., USA., Kommalapati A; School of Medicine, University of South Carolina, Columbia, South Carolina, USA., Tella SH; School of Medicine, University of South Carolina, Columbia, South Carolina, USA., DeAngelis C; Sunnybrook Health Sciences Center, Toronto, Ontario, Canada., Raisch DW; College of Pharmacy, University of New Mexico, Albuquerque, New Mexico, USA., Sartor O; Tulane University School of Medicine, New Orleans, Louisiana, USA., Hrushesky WJ; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA., Ray PS; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Yarnold PR; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Love BL; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Norris LB; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Knopf K; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.; Alameda Health System, Oakland, California, USA., Bobolts L; Oncology Analytics Inc., Plantation, Florida, USA.; Nova Southeastern University College of Pharmacy, Fort Lauderdale, Florida, USA., Riente J; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA., Luminari S; Hematology, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.; Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Reggio Emilia, Italy., Kane RC; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Hoque S; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA., Bennett CL; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA bennettc@cop.sc.edu.; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA.
Source: The oncologist [Oncologist] 2019 Apr; Vol. 24 (4), pp. 537-548. Date of Electronic Publication: 2019 Mar 06.
Publication Type: Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
Journal Info: Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Regulatory and Clinical Experiences with Biosimilar Filgrastim in the U.S., the European Union, Japan, and Canada.
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  Data: <searchLink fieldCode="AU" term="%22Chen+B%22">Chen B</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Nagai+S%22">Nagai S</searchLink>; Translational Research Center, The University of Tokyo Hospital, Tokyo, Japan.<br /><searchLink fieldCode="AU" term="%22Armitage+JO%22">Armitage JO</searchLink>; University of Nebraska School of Medicine, Omaha, Nebraska, USA.<br /><searchLink fieldCode="AU" term="%22Witherspoon+B%22">Witherspoon B</searchLink>; College of Medicine, Medical University of South Carolina, Charleston, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Nabhan+C%22">Nabhan C</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Godwin+AC%22">Godwin AC</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Yang+YT%22">Yang YT</searchLink>; Center for Health Policy and Media Engagement, George Washington University, Washington, D.C., USA.<br /><searchLink fieldCode="AU" term="%22Kommalapati+A%22">Kommalapati A</searchLink>; School of Medicine, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Tella+SH%22">Tella SH</searchLink>; School of Medicine, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22DeAngelis+C%22">DeAngelis C</searchLink>; Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.<br /><searchLink fieldCode="AU" term="%22Raisch+DW%22">Raisch DW</searchLink>; College of Pharmacy, University of New Mexico, Albuquerque, New Mexico, USA.<br /><searchLink fieldCode="AU" term="%22Sartor+O%22">Sartor O</searchLink>; Tulane University School of Medicine, New Orleans, Louisiana, USA.<br /><searchLink fieldCode="AU" term="%22Hrushesky+WJ%22">Hrushesky WJ</searchLink>; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Ray+PS%22">Ray PS</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Yarnold+PR%22">Yarnold PR</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Love+BL%22">Love BL</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Norris+LB%22">Norris LB</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Knopf+K%22">Knopf K</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.; Alameda Health System, Oakland, California, USA.<br /><searchLink fieldCode="AU" term="%22Bobolts+L%22">Bobolts L</searchLink>; Oncology Analytics Inc., Plantation, Florida, USA.; Nova Southeastern University College of Pharmacy, Fort Lauderdale, Florida, USA.<br /><searchLink fieldCode="AU" term="%22Riente+J%22">Riente J</searchLink>; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Luminari+S%22">Luminari S</searchLink>; Hematology, Arcispedale Santa Maria Nuova, Istituto di Ricovero e Cura a Carattere Scientifico, Reggio Emilia, Italy.; Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Reggio Emilia, Italy.<br /><searchLink fieldCode="AU" term="%22Kane+RC%22">Kane RC</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Hoque+S%22">Hoque S</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA.<br /><searchLink fieldCode="AU" term="%22Bennett+CL%22">Bennett CL</searchLink>; South Carolina Center of Economic Excellence for Medication Safety, College of Pharmacy, University of South Carolina, Columbia, South Carolina, USA bennettc@cop.sc.edu.; Arnold School of Public Health, University of South Carolina, Columbia, South Carolina, USA.; Hollings Cancer Center, Medical University of South Carolina, Charleston, South Carolina, USA.; William Jennings Bryan Dorn VA Medical Center, Columbia, South Carolina, USA.
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